Electroacupuncture for Mild-to-moderate Dry Eye

NCT05552820 | Completed DMC

• 1 other identifier: ShanghaiIAMM20220918
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

To determine if electroacupuncture acts as an dry eye treatment rather than a placebo, and identify if benefits are linked to corneal subbasal nerve changes and neuroimmunomodulatory indicators.

Conditions

Dry Eye

Keywords

Dry eye; Electroacupuncture

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Noninvasive Tear Breakup Time (NIBUT)

  The interval between a complete blink and the first breakup of tear film (indicated by a break or deformed Placido disc image on the screen) will be recorded. The measurements are carried out 3 times and the average value is considered as NIBUT.

  Baseline, Week 4, Week 8, Week 16, Week 28

Secondary Outcomes (9)

• Change From Baseline in Tear Meniscus Height (TMH)

  Baseline, Week 4, Week 8, Week 16, Week 28

• Change From Baseline in Ocular Surface Disease Index (OSDI)

  Baseline, Week 4, Week 8, Week 16, Week 28

• Change From Baseline in Corneal Fluorescein Staining (CFS)

  Baseline, Week 4, Week 8, Week 16, Week 28

• Change From Baseline in Corneal Topography

  Baseline, Week 4, Week 8, Week 16, Week 28

• Change From Baseline in Corneal and Conjunctival sensation

  Baseline, Week 4, Week 8, Week 16, Week 28

Other Outcomes (4)

• Change From Baseline in Generalized Anxiety Disorder (GAD-7)

  Baseline, Week 4, Week 8, Week 16, Week 28

• Change From Baseline in Patient Health Questionnaire-9 (PHQ-9)

  Baseline, Week 4, Week 8, Week 16, Week 28

• Change in morphological changes of the corneal basal nerve

  Baseline, Week 4

Study Arms (2)

Verum Electroacupuncture

EXPERIMENTAL

Verum electroacupuncture treatment will be given 3 times a week, at least 1 day apart , for consecutive 4 weeks with a 24-week follow-up. Each session lasts for 30 min.

Device: Verum Electroacupuncture

Sham Electroacupuncture

SHAM COMPARATOR

Sham electroacupuncture on non-acupoints plus non-penetrating plus no electrical stimulation will be given 3 times a week, at least 1 day apart , for consecutive 4 weeks with a 24-week follow-up. Each session lasts for 30 min.

Device: Sham Electroacupuncture

Interventions

Verum Electroacupuncture DEVICE

Acupoints: Cuanzhu (BL2), Taiyang (EX-HN5), Sibai (ST1), Sizhukong (TE23), Baihui (GV20), Fengchi (GB20), Hegu (LI4), Zusanli (ST36), Guangming (GB23), Sanyinjiao (SP6), and Taichong (LR3). All acupoints will be taken bilaterally, except Baihui (GV20). The subject is placed in the supine position with eyes close. After routine sterilization, the sterile polyethylene cylindrical needle pad will be adhered to the acupoints. Then, the sterile acupuncture needles (0.25 mm×0.40 mm, Hwato brand, China.) will be inserted into the skin through the needle pad. Twirling and lifting-thrusting manipulations will be performed on the acupoints until Deqi is reported by the subject. Two pairs of electrodes will be connected at the needle handles on BL2 and EX-HN5 with a 2 Hz, continuous-wave electro-stimulation provided by the electroacupuncture apparatus (SDZ-Ⅲ type, Hwato brand, China). The pulse amplitude is about 1-2 mA.

Verum Electroacupuncture

Sham Electroacupuncture DEVICE

Sham acupoints: SA1(1 cm above BL2), SA2 (1 cm above SJ23)，SA3 (1 cm above EX-HN5), SA4 (1 cm lateral to ST2), SA5 (the midpoint of the line between GV20 and right EX-HN1), SA6 (the midpoint of the line between GB20 and SJ16), SA7 (1 cm lateral to LI4), SA8 (the midpoint of the line between ST36 and GB34), SA9 (the midpoint of the line between GB37 and BL58), SA10 (1 cm backward to SP6), SA11 (the midpoint of the line between LR3 and SP4). After routine sterilization, placebo needles will be used (Streitberger, Asia-med GmbH). The tingling sensation produced when the Streitberger needle is fixed on the skin causes the subject to believe that the needle is piercing the skin, simulating a skin puncture. The electric stimulator is applied to bilateral SA1 and SA3 with no current output. The exterior appearance, indicator light, prompt tone of the sham device, and stimulation parameters are all indistinguishable from the normal one.

Sham Electroacupuncture

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients meeting the diagnostic criteria for dry eye according to the TFOS DEWS Ⅱ
• Ages 18-65 years, no gender limit

You may not qualify if:

• Diagnosed with severe dry eye
• Combined with other eye diseases (e.g. severe blepharitis, blepharospasm, conjunctival laxity, strabismus, amblyopia, glaucoma, cataract, fundus disease, ocular trauma)
• With active eye diseases or a history of eye surgery within 3 months
• Received acupuncture treatment or other dry eye treatment measures within 1 month that may influence the assessment of efficacy
• Previously experienced electroacupuncture intervention
• Pregnant or breastfeeding females
• Serious systemic diseases such as cardiovascular, cerebrovascular, hepatic, renal, and hematopoietic system and psychiatric disorders
• With autoimmune diseases such as Sjögren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, or ankylosing spondylitis
• With damaged, ulcerated, infected, or scarred skin at the selected acupoints
• Allergic to metal or tape

Sponsors & Collaborators

• Shanghai Institute of Acupuncture, Moxibustion and Meridian: lead
• Shanghai Eye Disease Prevention and Treatment Center: collaborator
• Eye & ENT Hospital of Fudan University: collaborator

Study Sites (1)

Guang Yang

Shanghai, 20030, China

Location

Related Publications (1)

• Lu YQ, Yang G, Li MY, Hong J, Yang YT, Wang XJ, Kong XH, Zhao Y, Ma Z, Huang XY, Zou YL, Zhou XT, Ma XP. Electroacupuncture for mild-to-moderate dry eye: study protocol for a multicentre, randomised, single-blind, sham-controlled trial. BMJ Open. 2023 Dec 6;13(12):e069369. doi: 10.1136/bmjopen-2022-069369.

  PMID: 38056935 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Xiaopeng Ma, MD, PhD

  Shanghai University of Traditional Chinese Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 23, 2022
• Study Start: December 12, 2023
• Primary Completion: October 18, 2025
• Study Completion: April 20, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

CN (1)